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Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis (Carotid)

This study has been withdrawn prior to enrollment.
(Study was never initiated and internal decision to discontinue initiation process)
Sponsor:
Collaborator:
Merck
Information provided by:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01321476
First received: March 14, 2011
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis. Tissue will be collected from patients undergoing carotid procedures as well as patients undergoing liver and/or intestinal biopsies. This lab study will examine the different types of proteins that play a role in developing heart plaque.


Condition
Heart Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • Demonstrated Plaques [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
    Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques.


Biospecimen Retention:   Samples With DNA

Carotid artery tissue Liver biopsy tissue Intestinal biopsy tissue Cell cultures


Estimated Enrollment: 25
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing a carotid, liver, and/or intestinal biopsy

Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Scheduled for a clinically indicated, standard-of-care carotid endarterectomy (CEA) OR scheduled for a clinically indicated, standard-of- care surgical, laparoscopic or endoscopic intestinal biopsy or excision OR scheduled for a clinically indicated, standard-of-care surgical, laparoscopic or endoscopic liver biopsy or partial resection/excision
  • Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

  • Age ≤18 years
  • Inability or unwillingness to consent and Authorization for use of PHI
  • FOR CAROTID PATIENTS - history of carotid trauma, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
  • FOR CAROTID PATIENTS - history of middle- or large-vessel vasculitis, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321476

Sponsors and Collaborators
Piedmont Healthcare
Merck
Investigators
Principal Investigator: Joseph Miller, MD Piedmont Heart Institute/Piedmont Hospital
  More Information

No publications provided

Responsible Party: Joseph Miller, MD, Piedmont Heart Institute
ClinicalTrials.gov Identifier: NCT01321476     History of Changes
Other Study ID Numbers: Carotid
Study First Received: March 14, 2011
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Heart Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013